Despite the fact that the US Food and Drug Administration (FDA) has yet to approve a biosimilar as interchangeable with its reference biological, many US states have been considering legislation on biosimilars substitution [1].

The pharmaceutical industry in India ranks third in the world in terms of volume and is the largest provider of generic medicines globally. However, concerns over the quality of generics manufacturing have affected utilization in India. This is demonstrated by poor sales in Jan Aushadhi outlets, which are government-run retail outlets providing generic medicines at an affordable price.

The European Medicines Agency (EMA) announced on 29 November 2018 that the Mutual Recognition Agreement between the European Union and the US had been extended to include five additional EU Member States, Belgium, Denmark, Estonia, Finland and Latvia.

Patient, healthcare and trade groups have warned that the North American Free Trade Agreement (NAFTA), now known as the US-Mexico-Canada Free Trade Agreement (USMCA) will keep American drug prices high.

On 9 November 2018, the US Food and Drug Administration (FDA) announced that it was taking new steps to modernize its inspections programme with a new way of assessing, recording and reporting the data from surveillance and pre-approval inspections for sterile drug products.

Australia’s High Court has rejected the nation’s competition watchdog’s efforts to revive an antitrust case accusing Pfizer of abusing its market power to maintain control of the Australian generics market for its cholesterol-lowering drug Lipitor (atorvastatin).

The European Medicines Agency (EMA) announced on 20 September 2018 that the Mutual Recognition Agreement between the European Union and the US had been extended to include one additional EU Member State, Portugal.